When the University of Iowa will rely on another IRB to provide oversight for my project

If you are planning to be the PI relying on another IRB, you have responsibilities to both the UI IRB and Reviewing IRB. The UI IRB is responsible for conducting the Human Research Protections Program review.  This means you will submit application materials to the UI IRB for the initial review and for any modifications, continuing reviews or reportable events for the duration of the study. However, the IRB of Record is responsible for providing the regulatory oversight for the research protocol. The Reviewing IRB will provide the IRB review for the initial review, and any modifications, continuing reviews, or reportable events for the duration of the study. A few responsibilities as a relying site PI under the SMART IRB agreement are:

• Following all requirements of their home institution with regard to ceded review, such as ensuring other reviews or sign-offs required by the institution have been completed before a study is activated.
• Working with the Lead Study Team and the POC from their home institution, as applicable, to incorporate site-specific required language into the consent template to be used at their institution.
• Providing the POC from their home institution with information regarding local Site Investigator or other Relying Site Study Team personnel changes.
• Reporting to their home institution POC any changes in conflict of interest (COI) disclosures and resulting changes in COI management plans related to the Research (i.e., the specific study or studies ceded to the Reviewing IRB).
• Reporting to the Lead Study Team (or designee) any changes (including funding changes and personnel changes), reportable events, and continuing review progress reports, for submission to the Reviewing IRB in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
• Promptly reporting to the Overall PI via the Lead Study Team (or designee) any unanticipated problems involving risks to subjects or others, subject injuries related to the research, or significant complaints that could impact the conduct of the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions. Significant complaints are defined as those that cannot be resolved by the study team and a) suggest an increased or unexpected new risk or harm or b) change the risk/benefit ratio of the Research. Other complaints should be reported in accordance with the Reviewing IRB’s policies and procedures.
• Promptly reporting to the Overall PI via the Lead Study Team (or designee) any potential noncompliance that occurs in relation to the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing of submission and content of such submissions.

For more information, please review the “Relying Institution Principal Investigator Checklist”.